BABY HEALTH CARE, INC.

FDA Device Registration & Listing · Newport Beach, CA, US · Registration 3011052946

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3011052946
FEI Number
3011052946
Entity Name
BABY HEALTH CARE, INC.
City/State/Country
Newport Beach, CA, US
Establishment Address
620 Newport Center Drive STE 1100, Newport Beach, CA 92660, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Baby Health Care, Inc. (Owner Number: 10089834)
Owner / Operator Contact Address
620 Newport Center Drive STE 1100, Newport Beach, CA 92660, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Guangzhou Wanyuan industrial co.,ltd. Guangzhou Wanyuan industrial co.,ltd. TKR HUANAN ELECTRONICS (DONGGUAN) CO., LTD. TKR HUANAN ELECTRONICS (DONGGUAN) CO., LTD. TKR

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JEQ Toothbrush, Powered Dental Class 1 872.6865 2024-03-27
EFW Toothbrush, Manual Dental Class 1 872.6855 2024-03-27
KDQ Bottle, Collection, Vacuum General Hospital Class 2 880.6740 2024-03-18
BSY Catheters, Suction, Tracheobronchial Anesthesiology Class 1 868.6810 2024-03-18
GCD Connector, Catheter General, Plastic Surgery Class 1 878.4200 2025-03-12

Official Correspondent

Kazumaas Yamafuji

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Baby Health Care, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K973236 Procter & Gamble Co. CREST TOOTHBRUSH WITH MICROSHIELD 1998-03-11

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011052946. Last updated year: 2026. Please use registration number 3011052946 when referencing this establishment in official correspondence.
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